Phase 2
N=37
A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00882310 ↗Enrolled (actual)
37
Serious AEs
23.1%
Results posted
Jun 2016
Primary outcome: Primary: Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Docetaxel (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Experience Dose Limiting Toxicities (DLTs) |
— | — |
| SECONDARY Time to Death |
— | — |
| SECONDARY Score on FACT-Hep (Version 4) |
— | — |
Summary
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. During the screening evaluation, subjects will have a physical exam and medical history taken by either the PI or a Co investigator. In addition, routine blood tests and radiological exams will be performed, to determine eligibility. Following enrollment, patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each cycle of treatment patients will have a physical examination, as well as routine blood work. The first scan will be done prior to initiation of treatment, and the next will be done at completion of chemotherapy. A short quality of life questionnaire will also be administered prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection.
- Ineligible for other high priority national or institutional studies.
- Time from surgical recovery greater than three weeks, but less than six weeks.
- All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy.
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months after completion of treatment. They must understand the risks of infertility possibly associated with adjuvant treatment.
- Clinical Parameters:
- Age ≥ 18 to ≤ 75 years old
- Performance status 0-2 (ECOG)
- Peripheral Neuropathy must be 1,500 ul
- White Blood Count > 3,000/ul
- Platelet count > 100,000/ul
- BUN 8.0 g/dl
- Serum Albumin > 2.5 mg/dl
- Total Bilirubin < 3.0 mg/dl
- AST ≤4.0 x ULN
- ALT ≤4.0 x ULN
- Alkaline Phosphatase ≤4.0 x ULN]
- CA 19-9 should be normal post surgery. Can still be put on protocol with elevation if clinically significant for inflammation or infection, not cancer
Exclusion Criteria
- Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
- Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body.
- Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
- Any prior investigational agent/therapy or any investigational agent/therapy while on protocol.
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drug formulated with polysorbate 80 will be excluded.
Data sourced from ClinicalTrials.gov (NCT00882310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.